Prospan

PATIENT INFORMATION LEAFLET

Leaflet attached to the packaging: information for the patient

PROSPAN, 35 mg / 5 ml, syrup

Dry extract of ivy leaf
Hederae helicis folii extractum siccum

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

This medicine should always be taken exactly as described in the patient leaflet or as directed by a doctor or pharmacist.

• Keep this leaflet, you may need to read it again.
• If you need advice or additional information, consult a pharmacist.
• If you experience any side effects, including any possible side effects not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• If after 7 days there is no improvement or you feel worse, contact your doctor.

Table of contents of the leaflet:

• 1. What is Prospan syrup and what is it used for
• 2. Important information before taking Prospan syrup
• 3. How to take Prospan syrup
• 4. Possible side effects
• 5. How to store Prospan syrup
• 6. Contents of the pack and other information

1. WHAT IS PROSPAN SYRUP AND WHAT IS IT USED FOR

Prospan syrup contains dry extract of ivy leaves. The main active ingredients of the dry extract of ivy leaves are triterpene saponins of glycosidic nature (α-hederin, hederagenin, and hederacoside C). Prospan syrup is used as an expectorant in productive cough (so-called wet cough). The preparation has secretolytic (thinning the bronchial secretion), spasmolytic (relaxing the smooth muscles of the bronchi), and cough-relieving effects. Due to these properties, the bronchial mucus in the airways becomes thinner and its expectoration is facilitated.

Indications for use

Prospan is a herbal medicine containing an extract of ivy leaves used as an expectorant in productive cough (so-called wet cough).

2. IMPORTANT INFORMATION BEFORE TAKING PROSPAN SYRUP

When not to take Prospan syrup:

• if you are hypersensitive to the active substance or to other plants of the Araliaceaefamily (araliaceae) or to any of the excipients,
• do not use in children under 2 years of age due to the risk of exacerbating respiratory symptoms.

Warnings and precautions

Before taking Prospan syrup, consult a doctor or pharmacist.
In case of persistent symptoms or the appearance of such symptoms as shortness of breath, fever, purulent or bloody expectoration, consult a doctor immediately.
Concomitant use of cough suppressants, such as codeine or dextromethorphan, is not recommended without consulting a doctor.
Cautious use is recommended in patients with gastric mucosa inflammation or stomach ulcers.
In rare cases, the medicine may irritate the mucous membranes.
Information for diabetics:the medicine does not contain sugar and can be used by people with diabetes.

Children

Persistent or recurrent cough in children between 2 and 4 years of age requires a medical diagnosis before starting treatment.

Prospan syrup and other medicines

Tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take, including those available without a prescription.
The medicine can be administered in combination with other medicines used during therapy, for example, with antibiotics. The medicine may enhance the effect of gastric mucosa irritants due to the content of saponins.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult a doctor or pharmacist before taking any medicine.
Studies on the safety of the medicine in pregnant women and its effect on fetal development have not been conducted. Therefore, the medicine can be used by pregnant and breastfeeding women only when, in the doctor's opinion, the benefit to the mother outweighs the potential risk to the fetus.

Driving and using machines

No adverse effect on the ability to drive vehicles, operate machinery, and mental performance has been found. The medicine does not contain alcohol.

The medicine contains sorbitol

A single dose (5 ml) contains 1.9 g of sorbitol. 2.5 ml of syrup contains 0.963 g of sorbitol = 0.08 bread units. Do not use in patients with rare hereditary fructose intolerance. In such cases, treatment should be carried out only after consulting a doctor.

3. HOW TO TAKE PROSPAN SYRUP

This medicine should always be taken exactly as described in the patient leaflet or as directed by a doctor or pharmacist. In case of doubt, consult a doctor or pharmacist.
Shake the syrup before use!
Adults and adolescents over 12 years:take 5 ml of syrup 3 times a day (which corresponds to 105 mg of dry extract of ivy leaves per day).
Children from 6 to 11 years:5 ml of syrup 2 times a day (which corresponds to 70 mg of dry extract of ivy leaves per day).
Children from 2 to 5 years:administer on average 2.5 ml of syrup 2 times a day (which corresponds to 35 mg of dry extract of ivy leaves per day).
Do not use in children under 2 years of age.

Administration of the syrup to children under 5 years should be consulted with a doctor.

A suitable measuring cup is used to measure the medicine.
The medicine should be taken in the morning, at noon, and in the evening.
The treatment period depends on the type of symptoms and their severity.
Treatment with the medicine should last at least 7 days, even in mild respiratory tract infections.
If symptoms persist for more than a week despite taking the medicine, consult a doctor or pharmacist
If you feel that the effect of Prospan syrup is too strong or too weak, consult a doctor or pharmacist.

Taking a higher dose of Prospan syrup than recommended (more than three times the daily dose)

Nausea, vomiting, and diarrhea caused by the presence of sorbitol in the medicine may occur.
In this case, consult a doctor.

Missing a dose of Prospan syrup

Do not take a double dose to make up for a missed dose.

Stopping Prospan syrup

In case of any further doubts about the use of this medicine, consult a doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Very common: in more than 1 in 10 patients.
Common: in 1-10 in 100 patients.
Uncommon: in 1-10 in 1,000 patients.
Rare: in 1-10 in 10,000 patients.
Very rare: in less than 1 in 10,000 patients.
Not known: cannot be estimated from the available data.

Possible side effects

Very rarely, after taking medicines containing ivy extract, allergic reactions may occur, such as shortness of breath, swelling, redness, and itching of the skin.
In sensitive individuals, uncommonly, gastrointestinal disorders may occur, such as nausea, vomiting, diarrhea, and a laxative effect associated with the content of sorbitol.

Reporting side effects

If you experience any side effects, including any possible side effects not listed in this leaflet, tell your doctor or pharmacist, or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: 22 49-21-301, fax: 22 49-21-309, e-mail:
ndl@urpl.gov.pl.
Side effects can also be reported to the marketing authorization holder or its representative.
Reporting side effects will help to gather more information on the safety of the medicine.

5. HOW TO STORE PROSPAN SYRUP

Keep the medicine out of the sight and reach of children.
Store in a temperature not exceeding 25°C.
Slight cloudiness of the syrup is due to the presence of plant ingredients.
This condition does not affect the efficacy of the medicine.
Do not use this medicine after the expiry date stated on the packaging.
The expiry date refers to the last day of the specified month.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Prospan syrup contains

The active substance of the medicine is dry extract of ivy leaves ( Hederae helicis folii extractum
siccum).

• 100 ml of syrup contains 0.7 g of dry extract of Hedera helixL., folium(ivy leaf) (5-7.5:1), extraction solvent: ethanol 30 % (m/m).
• The other ingredients (excipients) are: liquid crystallizable sorbitol (E420), potassium sorbate (E 202), anhydrous citric acid, xanthan gum, cherry flavor, purified water.

The syrup does not contain alcohol.
The syrup does not contain sugar and can be used by diabetics.

What Prospan syrup looks like and what the pack contains

The immediate packaging of Prospan syrup consists of brown glass bottles with a flow restrictor made of polyethylene with a capacity of 100 ml or 200 ml of syrup and a polyethylene (HDPE) cap with a guarantee ring, and a measuring cup made of polypropylene in a cardboard box.

Marketing authorization holder and manufacturer

Engelhard Arzneimittel GmbH & Co. KG
Herzbergstraße 3, 61138 Niederdorfelden, Germany
Date of last revision of the leaflet: January 2019